MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG COMBO CASSETTE (20/10MIU/ML); HCG PREGNANCY TEST

Model Number	92215
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: an investigation was performed on retention product for the reported lot number.Retention product was tested with qc cut-off serum standard (10 miu/ml hcg).All devices produced expected positive results at the read time and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities and all quality control specifications were met.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Event or Problem Description
On (b)(6) 2018, the patient was tested for pregnancy prior to an unspecified procedure.A serum sample was collected and produced a negative hcg result using an alere hcg combo cassette at a read time of five to six minutes.However, the customer reported observing a faint positive line appear approximately one minute later.Per the customer, a timer was not used for the test.The customer expected a negative result because the patient was post-menopausal.The alere hcg combo cassette test was repeated three additional times and a faint line continued to appear approximately one minute after the read.A serum quantitative test was performed and produced a positive hcg result of ">5." the customer was unable to further clarify the quantitative result but stated the hcg result indicated the patient was positive for pregnancy.The customer was unable to provide information regarding whether the unspecified procedure was performed but no adverse patient outcome reported.Troubleshooting was conducted with the customer.The customer was advised of the requirement of a timer to ensure the result is interpreted at the designated read time.False negative results may occur when the levels of hcg are below the sensitivity level of the test.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: ALERE HCG COMBO CASSETTE (20/10MIU/ML)
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7719341
• Report Number: 2027969-2018-00091
• Device Sequence Number: 19270931
• Product Code: JHI
• UDI-Device Identifier: 10815845020123
• UDI-Public: (01)10815845020123(17)200131(10)HCG8020008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 92215
• Device Lot Number: HCG8020008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1